Clinical Evaluation of Tunneled Coronally Advanced Flap v.s Coronally Advanced Flap With Graft for Gingival Recession

Clinical Evaluation of Tunneled Coronally Advanced Flap (TCAF) Versus Coronally Advanced Flap (CAF) Combined With Connective Tissue Graft in the Treatment of Isolated RT2 Gingival Recession Sites: A Randomized Clinical Trial

The goal of this clinical trial is to evaluate gingival recession depth reduction using tunneled coronally advanced flap compared to coronally advanced flap, both combined with connective tissue graft in patients with isolated RT2 gingival recession sites.

Study Overview

• Status: Recruiting
• Conditions: Gingival Recession, Localized
• Intervention / Treatment: Procedure: Tunneled coronal advanced flap with connective tissue graft; Procedure: Coronally advanced flap with connective tissue graft

Detailed Description

Gingival recession can cause clinical conditions that could be of main concern for patients. Techniques aiming for coverage of the gingival recession aim to address dentin hypersensitivity, non-carious cervical lesions (NCCLs) and enhance patient's esthetics (Cortellini & Bissada, 2018). Mid-buccal gingival recessions have been associated with patient's esthetic discomfort (Zucchelli & Mounssif, 2015). Most of the studies in the literature focus on the treatment of RT1 recession as they have the most favorable prognosis of full root coverage (Barootchi et al., 2020). Despite most studies focusing their attention on RT1 cases, RT2 defects are found to be the most prevalent type with 88.8% among patients according to (Romandini et al., 2020).

The coronally advanced flap and the tunneling technique are the most commonly performed surgical approaches for treating gingival recessions. However, these two approaches have commonly been regarded as alternatives to each other, with clinicians choosing to perform only one of them during root coverage procedures.

(Barootchi & Tavelli, 2022) aimed in his conducted case series to designate a surgical technique to treat isolated RT2 gingival recession defects in which he was trying to achieve and combine the advantage of both better access and graft stabilization in CAF and the preservation of the integrity of the papilla and better blood supply to the graft present in tunneling technique. The study concluded that the combination of both techniques in the same surgical design can have the potential to enhance flap and graft vascularization and improve clinical, esthetic, and patient-reported outcomes. To our knowledge, there is no conducted randomized clinical trials comparing the tunneled coronally advanced flap technique to the coronally advanced flap for gingival depth reduction.

So, this clinical trial aims to address this gap of the literature.

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Omar H Sallam, MSc; Phone Number: +201113203236; Email: omar.sallam@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Faculty of Dentistry, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Patients age 18 years or older.
2. Isolated recession defect classified as RT2.
3. Patients with healthy systemic condition.
4. Clinical indication and/or patient request for root coverage.
5. O'Leary index less than 20%.

Exclusion Criteria:

1. Pregnant females
2. Smokers: a contraindication for any plastic periodontal surgery.
3. Unmotivated and uncooperative patients with poor oral hygiene
4. Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or parafunctional habits.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tunneled coronal advanced flap with connective tissue graft; TCAF involves the elevation of one trapezoidal surgical papilla at the papilla with less interproximal clinical attachment loss, by a slightly divergent vertical incision extending beyond the mucogingival junction is done then a horizontal incision at a distance equal to the recession depth plus 1 mm apical to the papilla tip just as the conventional coronally advanced flap (CAF). Then a tunneling knife will be used to perform the intra-sulcular incision on the treated site and on the tooth adjacent to the papilla that will be preserved for tension-free flap advancement. The midfacial aspect of the tooth will be elevated with tunneling knives while the surgical papilla will be elevated in a split-thickness manner. . The anatomical papilla will be de-epithelialized, either with a surgical blade or micro scissors, while the other papilla will be gently mobilized with a tunneling instrument. . The harvested connective tissue graft will be inserted underneath the flap	Procedure: Tunneled coronal advanced flap with connective tissue graft; Tunneled coronal advanced flap with connective tissue graft to treat isolated RT2 gingival recession sites.
Active Comparator: Coronally advanced flap with connective tissue graft; A trapezoidal-shaped flap will be elevated with a split-full-split approach in the coronal-apical direction: The surgical papillae will be elevated by split thickness keeping the blade almost parallel to the root.; The soft tissue apical to the root exposure will be elevated in a full thickness manner to expose 3-4mm of bone apical to the bone dehiscence. This was done to include the periosteum in the thickness of that central portion of the flap covering the avascular root exposure.; The releasing vertical incisions will be elevated by split thickness keeping the blade parallel to the bone thus leaving the periosteum to protect the underlying bone in the lateral areas of the flap.; The part of the flap apical to bone exposure will be elevated by split-thickness, this step will be done so it is possible to move the flap passively in the coronal direction. The harvested connective tissue graft will be inserted underneath the flap	Procedure: Coronally advanced flap with connective tissue graft; Coronally advanced flap with connective tissue graft to treat isolated RT2 gingival recession sites

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival Recession Depth	It's measured as the distance between cemento-enamel junction (CEJ), and gingival margin (GM) using periodontal probe.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of mean root coverage (MRC%)	(Preoperative vertical recession depth - Postoperative vertical recession/preoperative vertical recession) x 100 [%]	6 months
Percentage of complete root coverage (CRC%)	Number of defect sites with complete root coverage/ Total number of recession sites treated x 100 [%]	6 months
Gingival Recession Width	Measured at the widest point (it is the distance between the mesial gingival margin and the distal gingival margin of the tooth)	6 months
Gingival Thickness	Measured using transgingival needle probing using anesthesic needle a rubber stopper	6 months
Keratinized Tissue Width	Measured as the distance between the gingival margin and the mucogingival junction (MGJ).	6 months
Clinical Attachment Level	Measured from the CEJ to the bottom of the gingival sulcus.	6 months
Probing Pocket Depth	Measured from the gingival margin to the bottom of the gingival sulcus.	6 months
Pink Esthetic Score	It's a score by (Fürhauser et al., 2005) based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture. Each variable is assessed with a 0-1-2 score, with 2 being the best and 0 being the poorest score.	6 months
Post-operative pain	Visual Analogue Scale (VAS) with numerical scale from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 weeks postoperatively.	2 weeks
Post-operative patient satisfaction	A 3-item questionnaire will be given to the patients to be answered using a 7-point answer scale for assessing their satisfaction with the whole surgical procedure and the achieved results of the procedure performed.	2 weeks, 6 months
Root coverage esthetic score	(Cairo et al., 2009) This score evaluates five variables: level of the gingival margin (GM) , marginal tissue contour (MTC), soft tissue texture (STT) , mucogingival junction (MGJ) alignment , and gingival color (GC).; GM: Zero point for failure of root coverage (gingival margin apical or equal to the baseline recession); 3 points partial root coverage; 6 points CRC.; MTC: Zero point irregular gingival margin (does not follow the CEJ); 1 point -proper marginal contour/ scalloped gingival margin (follows the CEJ).; STT: Zero point for scar formation and/or keloid-like appearance; I point absence of scar or keloid formation.; MGJ: Zero point -MGJ not aligned with the MGJ of adjacent teeth; 1 point if the MGJ aligned with the MGJ of adjacent teeth.; GC: Zero point color of tissue varies from gingival color at adjacent teeth; 1 point normal color and integration with the adjacent soft tissues.10 is the ideal esthetic score	6 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Engy Ahmed, PhD, Cairo University; Study Chair: Omar A Ashour, PhD, Cairo University; Study Chair: Yehia H Amer, PhD, Cairo University; Principal Investigator: Omar H Sallam, MSc, Cairo University

Publications and helpful links

General Publications

• Barootchi S, Tavelli L. Tunneled coronally advanced flap for the treatment of isolated gingival recessions with deficient papilla. Int J Esthet Dent. 2022 Feb 17;17(1):14-26.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: August 11, 2024
• First Submitted That Met QC Criteria: August 11, 2024
• First Posted (Actual): August 14, 2024

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 11, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: CAF; RT2; TCAF; Gingival recession depth reduction
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: Perio2804

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: I will check with my study chair.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No